In the process of removing particulates from bioreactor streams or conducting chromatography, a mixture of chemical substances may be resolved or separated by means of their selective retention as they are transported by a moving fluid or buffer solution through a slurry of particulates or particulates or resins packed in a chromatography column. A solution of the substances to be separated is referred to as the mobile phase of the system. The particulates or resin is known as the stationary phase and comprises finely divided particles which may be in the form of a gel or a solid, a micro or macroporous particle, fiber or fibrous material.
Typically, chromatography columns, referred to herein as simply a “column,” comprise a hollow, vertically disposed non-cylindrical or cylindrical housing including, at the upper end, a liquid dispensing section through which the mobile phase is dispensed to the porous resin. A liquid collection section is typically located at the lower end of the column. The resin through which the mobile phase percolates is generally located between these two sections. Typically, the column is made from a rigid material, such as stainless steel, glass, or polyvinylchloride. The column is typically designed for multiple uses, requiring a cleaning process prior to each use, which can often be lengthy in duration and high in cost.
In the field of bio-manufacturing, there has been a well recognized need to optimize the contact time and area between the liquid and the resin. Techniques such as simulated moving bed chromatography have been developed along with packed-bed chromatography to most effectively perform the desired unit operation. Traditional columns may not allow for the easy conversion between slurried, or simulated moving bed chromatography, and packed-bed chromatography.
Similarly, the use of flocculants, fiber filter beds or filter aids that perform filtration to remove particulates from the mobile phase can require suspension in one mode of operations and repacking into a packed bed in another mode of operation.
Thus, a need exists for a new, single use or disposable system for adjusting particulate slurry or chromatographic operation, such as quickly switching between slurried and packed-bed operation and easily adjusting the height and volume of the bed or column.
Further, when filtration or chromatography is performed in a cleanroom environment, maintaining the desired low level of particulates in the ambient environment is often compromised by open tank operations and/or the need to thoroughly clean large vessels between batches. Restoring a cleanroom to a desired level, e.g., class 10000 or ISO 7, following a batch run can require lengthy air filtration cycles. Thus, there is a need to reduce the amount of cleaning needed in such systems so as to minimize the amount of time between batches.